---
schema_version: "secwatch.filing_event.v1"
accession: "0000805928-25-000112"
form_type: "8-K"
ticker: "AXGN"
cik: "0000805928"
company_name: "Axogen, Inc."
filed_at: "2025-08-25T23:59:59+00:00"
generated_at: "2026-05-17T10:27:05.069728+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA extends PDUFA date for Axogen's Avance Nerve Graft BLA to Dec 5, 2025

## Summary
- FDA deemed Axogen's August 22 submission a Major Amendment, extending PDUFA goal date by three months to Dec 5, 2025.
- FDA now anticipates providing product labeling feedback in November 2025.
- Submission included substantial new manufacturing and facility data not previously reviewed by the Agency.

## SEC filing metadata
- accession: 0000805928-25-000112
- form_type: 8-K
- ticker: AXGN
- cik: 0000805928
- company_name: Axogen, Inc.
- filed_at: 2025-08-25T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/805928/000080592825000112/0000805928-25-000112-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/805928/000080592825000112/axgn-20250822.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000805928-25-000112
- JSON: https://secwatch.observer/filing/0000805928-25-000112.json
- Plain text: https://secwatch.observer/filing/0000805928-25-000112.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.